FDA 510(k), K212659, More-Cell-System
FDA 510(k), K212659, More-Cell-System
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510(K) Number: K212659
Device Name: More-Cell-System
Manufacturer: Agency for Medical Innovations GmbH
Device Classification Name: Containment System, Laparoscopic Power Morcellation, With Instrument Port
Regulation Number: 884.4050
Classification Product Code: PMU
Date Received: 08/23/2021
Decision Date: 11/10/2021
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: More-Cell-System
Manufacturer: Agency for Medical Innovations GmbH
Device Classification Name: Containment System, Laparoscopic Power Morcellation, With Instrument Port
Regulation Number: 884.4050
Classification Product Code: PMU
Date Received: 08/23/2021
Decision Date: 11/10/2021
Regulation Medical Specialty: Obstetrics/Gynecology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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